NCT02008058

Brief Summary

This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 23, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

March 30, 2020

Status Verified

April 1, 2019

Enrollment Period

3.2 years

First QC Date

December 6, 2013

Last Update Submit

March 27, 2020

Conditions

Metastatic Castrate-Resistant Prostate Cancer

Keywords

Metastatic Castrate-Resistant Prostate CancerLCCC 1231Lineberger Comprehensive Cancer CenterUNC LinebergerProstate CancerPain

Outcome Measures

Primary Outcomes (1)

  • Proportion of pain palliation responders

    Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.

    6 weeks

Secondary Outcomes (5)

  • Clinical significance of pain score changes

    6 weeks

  • Prevalence and trajectory of pain progression and pain palliation

    3 weeks

  • Quantifying analgesic medication use

    26 months

  • Frequency of pain reporting

    7 days

  • Web-avidity of patients

    6 weeks

Study Arms (1)

Single Arm

Surveys, diaries, clinical assessments of men with metastatic castrate-resistant prostate cancer

Behavioral: Survey

Interventions

SurveyBEHAVIORAL

Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study. Patients will remain on study for up to 26 months (slightly longer than the expected median survival in this population based on data from docetaxel, abiraterone, and MDV3100 pivotal phase 3 trials).

Also known as: Webcore telephone survey system
Single Arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oncology clinic

You may qualify if:

  • The subject must be ≥ 18 years old on the day of consent.
  • The subject is able to understand written and spoken English
  • The patient must have histologically or cytologically confirmed prostate adenocarcinoma.
  • The subject must have castration-resistant prostate cancer (CRPC)
  • The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).
  • The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy).
  • The subject must be starting any line treatment post-androgen deprivation/antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; sipuleucel-T; Radium 223.
  • The subject owns or has regular access to a telephone (cellular or land line).
  • The subject is willing and able to self-report pain and analgesic use via an automated telephone system.
  • The subject is willing and able to provide informed consent.

You may not qualify if:

  • The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsPain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ethan Basch, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 11, 2013

Study Start

January 23, 2014

Primary Completion

March 31, 2017

Study Completion

September 30, 2017

Last Updated

March 30, 2020

Record last verified: 2019-04

Locations

US(4)